Podcast
Questions and Answers
What is a primary characteristic of a one-sided hypothesis?
What is a primary characteristic of a one-sided hypothesis?
- It specifies the expected direction of difference. (correct)
- It allows for the possibility of effects in both directions.
- It indicates no clear expectation of the direction of effect.
- It requires clinical equipoise to be valid.
When should a two-sided hypothesis be utilized?
When should a two-sided hypothesis be utilized?
- When conducting non-randomized trials.
- When previous studies showed a definitive result.
- When the direction of the effect is uncertain. (correct)
- When researchers have a strong expectation of the outcome.
What does clinical equipoise require for conducting a clinical trial?
What does clinical equipoise require for conducting a clinical trial?
- Preference for one treatment based on prior studies.
- Absolute certainty regarding treatment effectiveness.
- Genuine uncertainty in the expert community about treatment benefits. (correct)
- A unanimous agreement among doctors about treatment options.
Why is it important to state the hypothesis at the beginning of research?
Why is it important to state the hypothesis at the beginning of research?
How should the primary objective of a study relate to the study hypothesis?
How should the primary objective of a study relate to the study hypothesis?
What should be included in the protocol for recording adverse events?
What should be included in the protocol for recording adverse events?
Which of the following best describes what should be outlined in a study protocol?
Which of the following best describes what should be outlined in a study protocol?
What is the purpose of including a flow diagram in a study protocol?
What is the purpose of including a flow diagram in a study protocol?
What should the protocol specify about data management?
What should the protocol specify about data management?
Which aspect is crucial for ensuring the safety of study participants?
Which aspect is crucial for ensuring the safety of study participants?
What aspect should be detailed in a qualitative study's protocol?
What aspect should be detailed in a qualitative study's protocol?
What is the purpose of the Data and Safety Monitoring Board (DSMB) in a study?
What is the purpose of the Data and Safety Monitoring Board (DSMB) in a study?
Which of the following is NOT an expected outcome that should be explained in a study?
Which of the following is NOT an expected outcome that should be explained in a study?
What should a protocol include regarding the dissemination of results?
What should a protocol include regarding the dissemination of results?
What is crucial to include in a study protocol concerning anticipated problems?
What is crucial to include in a study protocol concerning anticipated problems?
Why should the protocol specify a timeline for each project's phase?
Why should the protocol specify a timeline for each project's phase?
What should be outlined in the publication policy of a study?
What should be outlined in the publication policy of a study?
What is a primary focus of quality assurance in a study protocol?
What is a primary focus of quality assurance in a study protocol?
What is the purpose of stating a hypothesis before conducting a study?
What is the purpose of stating a hypothesis before conducting a study?
Which type of research question aims to understand how and why mental health problems arise?
Which type of research question aims to understand how and why mental health problems arise?
What is the main focus when writing a research protocol?
What is the main focus when writing a research protocol?
In studies without a stated hypothesis, what is essential to have?
In studies without a stated hypothesis, what is essential to have?
What should researchers consider about the design of their study?
What should researchers consider about the design of their study?
Which of the following principles is NOT mentioned as part of good research design?
Which of the following principles is NOT mentioned as part of good research design?
Which part of the research protocol includes the context and rationale for the study?
Which part of the research protocol includes the context and rationale for the study?
When designing a study, why is it beneficial for the design to be collaborative?
When designing a study, why is it beneficial for the design to be collaborative?
What is the primary purpose of stating research objectives?
What is the primary purpose of stating research objectives?
In the context of research, what is typically included in the analysis plan?
In the context of research, what is typically included in the analysis plan?
Which component is essential for justifying the significance of a research study?
Which component is essential for justifying the significance of a research study?
What is the role of disseminating research findings?
What is the role of disseminating research findings?
Which of the following describes a hypothesis in research?
Which of the following describes a hypothesis in research?
What should be included to put the research in context within the field?
What should be included to put the research in context within the field?
What is crucial to maintain when constructing a logical flow in research presentation?
What is crucial to maintain when constructing a logical flow in research presentation?
Which aspect is not typically covered in the methods section of a research proposal?
Which aspect is not typically covered in the methods section of a research proposal?
What is the primary aim of the controlled trial mentioned?
What is the primary aim of the controlled trial mentioned?
Which option best describes the difference between an aim and an objective?
Which option best describes the difference between an aim and an objective?
What is stated as a primary hypothesis of the trial?
What is stated as a primary hypothesis of the trial?
Which aspect of the study is essential for comparison groups within the sample?
Which aspect of the study is essential for comparison groups within the sample?
Which of the following is NOT part of the methods section in a study design?
Which of the following is NOT part of the methods section in a study design?
What is the purpose of describing the setting in a study?
What is the purpose of describing the setting in a study?
In terms of study measures, what is critical for ensuring accurate data collection?
In terms of study measures, what is critical for ensuring accurate data collection?
Why is it important to specify outcomes in a study?
Why is it important to specify outcomes in a study?
What role do systematic literature reviews play in research preparation?
What role do systematic literature reviews play in research preparation?
Why is it essential to have a well-defined primary research question?
Why is it essential to have a well-defined primary research question?
What is the primary purpose of developing research objectives in a study?
What is the primary purpose of developing research objectives in a study?
How should additional questions in a research study be handled?
How should additional questions in a research study be handled?
What factors should be clearly stated in a grant proposal's primary research question?
What factors should be clearly stated in a grant proposal's primary research question?
What is a key benefit of involving service users in research projects?
What is a key benefit of involving service users in research projects?
Which of the following would NOT typically be included in a research protocol?
Which of the following would NOT typically be included in a research protocol?
What aspect of a protocol often requires detailed explanation to assess its feasibility?
What aspect of a protocol often requires detailed explanation to assess its feasibility?
Identifying confounding variables is essential during which phase of a research protocol?
Identifying confounding variables is essential during which phase of a research protocol?
Which of the following weaknesses is highlighted regarding the aims of the research?
Which of the following weaknesses is highlighted regarding the aims of the research?
In what way can service users influence the research methodology?
In what way can service users influence the research methodology?
Why is it important to have a clear timeline in the research protocol?
Why is it important to have a clear timeline in the research protocol?
What characteristic is NOT considered a strength in the protocol review?
What characteristic is NOT considered a strength in the protocol review?
What does the PICO(T) framework specifically help define in a research question?
What does the PICO(T) framework specifically help define in a research question?
How does a narrow population definition impact internal and external validity?
How does a narrow population definition impact internal and external validity?
What does a two-sided hypothesis indicate?
What does a two-sided hypothesis indicate?
Which of the following statements about a good research question is true?
Which of the following statements about a good research question is true?
Which characteristic is essential for formulating a null hypothesis?
Which characteristic is essential for formulating a null hypothesis?
Which approach is recommended in research protocol development?
Which approach is recommended in research protocol development?
What is the primary focus when defining a research study's objectives?
What is the primary focus when defining a research study's objectives?
What does clinical equipoise ensure in randomized trials?
What does clinical equipoise ensure in randomized trials?
What benefit does a well-structured hypothesis provide for a research study?
What benefit does a well-structured hypothesis provide for a research study?
Why is it crucial to define the study population accurately?
Why is it crucial to define the study population accurately?
What is a composite outcome in hypothesis development?
What is a composite outcome in hypothesis development?
What characterizes a more restrictive sampling strategy in research?
What characterizes a more restrictive sampling strategy in research?
Which of the following best describes the role of a research objective?
Which of the following best describes the role of a research objective?
What is the primary research question addressed by the study?
What is the primary research question addressed by the study?
What was the hypothesis of the research?
What was the hypothesis of the research?
Why is developing a well-structured research question critical?
Why is developing a well-structured research question critical?
What should be included in the rationale and background information section of a research protocol?
What should be included in the rationale and background information section of a research protocol?
Which of the following describes a primary objective in a research study?
Which of the following describes a primary objective in a research study?
What is a critical aspect of the study design regarding participant criteria?
What is a critical aspect of the study design regarding participant criteria?
What is the primary role of hypotheses in research?
What is the primary role of hypotheses in research?
Which element is essential for the safety considerations outlined in a research protocol?
Which element is essential for the safety considerations outlined in a research protocol?
What is a primary goal when formulating a research question?
What is a primary goal when formulating a research question?
Which of the following best describes the difference between 'aims' and 'objectives' in research?
Which of the following best describes the difference between 'aims' and 'objectives' in research?
In a randomized controlled trial, what aspect is crucial for maintaining study integrity?
In a randomized controlled trial, what aspect is crucial for maintaining study integrity?
What type of study design is commonly chosen for testing the effectiveness of interventions?
What type of study design is commonly chosen for testing the effectiveness of interventions?
What should be included as part of the introduction in a research protocol?
What should be included as part of the introduction in a research protocol?
What is the intended result of conducting a critical appraisal of the research question?
What is the intended result of conducting a critical appraisal of the research question?
What is the significance of measuring reliability and validity in study measures?
What is the significance of measuring reliability and validity in study measures?
Which type of research question focuses on understanding the development of mental health problems?
Which type of research question focuses on understanding the development of mental health problems?
Which component should be described in detail within the methodology section of the protocol?
Which component should be described in detail within the methodology section of the protocol?
What is crucial when specifying study outcomes in research?
What is crucial when specifying study outcomes in research?
Which of the following is NOT mentioned as a key component of ethical considerations in research?
Which of the following is NOT mentioned as a key component of ethical considerations in research?
Why is it necessary to identify gaps in the current literature during the research design process?
Why is it necessary to identify gaps in the current literature during the research design process?
What role does stakeholder feedback play in developing research questions?
What role does stakeholder feedback play in developing research questions?
What role does a flow diagram play in a study protocol?
What role does a flow diagram play in a study protocol?
In the context of qualitative analysis, which tool is commonly used for identifying themes?
In the context of qualitative analysis, which tool is commonly used for identifying themes?
What does including adverse event reporting procedures in a protocol ensure?
What does including adverse event reporting procedures in a protocol ensure?
What is the primary objective of dissemination in research?
What is the primary objective of dissemination in research?
What is one essential component of the methods section in a study design?
What is one essential component of the methods section in a study design?
What is a critical element that must be included in the analysis plan of a study?
What is a critical element that must be included in the analysis plan of a study?
In a research protocol, what is the primary purpose of the aims and objectives section?
In a research protocol, what is the primary purpose of the aims and objectives section?
Which aspect of study design is essential for ensuring its replicability?
Which aspect of study design is essential for ensuring its replicability?
What is a crucial reason for stating a hypothesis prior to conducting a study?
What is a crucial reason for stating a hypothesis prior to conducting a study?
What role does Public and Patient Involvement (PPI) play in clinical research?
What role does Public and Patient Involvement (PPI) play in clinical research?
What should be outlined in the dissemination plans of a research protocol?
What should be outlined in the dissemination plans of a research protocol?
How should variables be categorized or transformed in a research analysis plan?
How should variables be categorized or transformed in a research analysis plan?
What is a potential impact of research findings on healthcare systems?
What is a potential impact of research findings on healthcare systems?
What is a key responsibility of stakeholders in the research dissemination process?
What is a key responsibility of stakeholders in the research dissemination process?
Which characteristic is essential for a hypothesis in research?
Which characteristic is essential for a hypothesis in research?
What is typically included in the methods section of a research study?
What is typically included in the methods section of a research study?
What part of a research study is critical for ensuring participant safety and ethical conduct?
What part of a research study is critical for ensuring participant safety and ethical conduct?
Which aspect is NOT typically included in a research protocol's analysis plan?
Which aspect is NOT typically included in a research protocol's analysis plan?
How does qualitative research typically differ from quantitative research regarding hypotheses?
How does qualitative research typically differ from quantitative research regarding hypotheses?
What is a primary purpose of quality assurance in clinical research?
What is a primary purpose of quality assurance in clinical research?
Which component is essential for the informed consent process in a research protocol?
Which component is essential for the informed consent process in a research protocol?
In terms of data management, what is essential during statistical analysis?
In terms of data management, what is essential during statistical analysis?
Why is it critical to discuss anticipated problems in the research protocol?
Why is it critical to discuss anticipated problems in the research protocol?
What should the dissemination policy in a study protocol clarify?
What should the dissemination policy in a study protocol clarify?
How can the quality of the protocol benefit the research process?
How can the quality of the protocol benefit the research process?
Which ethical consideration is critical in clinical research protocol?
Which ethical consideration is critical in clinical research protocol?
What element should be included in the project management section of a study protocol?
What element should be included in the project management section of a study protocol?
What does the budget section of the protocol need to include?
What does the budget section of the protocol need to include?
What should be addressed regarding missing or spurious data in a study?
What should be addressed regarding missing or spurious data in a study?
What is one of the key aims a research protocol should fulfill?
What is one of the key aims a research protocol should fulfill?
What is the significance of specifying a timeline for each project phase in a protocol?
What is the significance of specifying a timeline for each project phase in a protocol?
Which aspect should a qualitative study's protocol detail?
Which aspect should a qualitative study's protocol detail?
What role does the Data and Safety Monitoring Board (DSMB) play in a study?
What role does the Data and Safety Monitoring Board (DSMB) play in a study?
Flashcards
One-sided hypothesis
One-sided hypothesis
Specifies the expected direction of the difference between groups.
Two-sided hypothesis
Two-sided hypothesis
States there's a difference between groups, but doesn't specify which group is better.
Clinical Equipoise
Clinical Equipoise
Ethical principle for clinical trials. It requires uncertainty among experts about which treatment is better.
Research Objective
Research Objective
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Hypothesis Development
Hypothesis Development
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Procedures
Procedures
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Observations in Research
Observations in Research
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Laboratory Investigations
Laboratory Investigations
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Focus Groups
Focus Groups
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Safety Considerations in Research
Safety Considerations in Research
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Sample Size
Sample Size
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Power of a Study
Power of a Study
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Significance Level
Significance Level
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Handling Missing Data
Handling Missing Data
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Qualitative Data Analysis
Qualitative Data Analysis
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Quality Assurance System
Quality Assurance System
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Expected Outcome
Expected Outcome
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Dissemination and Publication Policy
Dissemination and Publication Policy
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Main Research Question
Main Research Question
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Hypothesis
Hypothesis
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Research Methodology
Research Methodology
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Analysis plan
Analysis plan
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Dissemination Plan
Dissemination Plan
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Define key terms
Define key terms
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Research Gaps
Research Gaps
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Addressing Research Gaps
Addressing Research Gaps
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What is a hypothesis?
What is a hypothesis?
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When should a hypothesis be formulated?
When should a hypothesis be formulated?
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Why have a primary hypothesis?
Why have a primary hypothesis?
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What about qualitative research?
What about qualitative research?
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Give an example of a good hypothesis.
Give an example of a good hypothesis.
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What is aetiology & mechanisms research?
What is aetiology & mechanisms research?
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What is treatment research?
What is treatment research?
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What is experiences research?
What is experiences research?
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Methodology
Methodology
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Objectives
Objectives
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Aim
Aim
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Study Design
Study Design
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Study Population
Study Population
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Intervention
Intervention
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Fidelity
Fidelity
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Research Question
Research Question
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Research Protocol
Research Protocol
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Primary Research Question
Primary Research Question
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Identifying Research Gaps
Identifying Research Gaps
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Service User Involvement
Service User Involvement
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Review Questions with Stakeholders
Review Questions with Stakeholders
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Accessible Research
Accessible Research
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Impact of Research
Impact of Research
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Gant Chart
Gant Chart
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Protocol Review
Protocol Review
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Research Aim
Research Aim
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Research Hypothesis
Research Hypothesis
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Rationale
Rationale
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Project Summary
Project Summary
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Safety Considerations
Safety Considerations
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Time Frame
Time Frame
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Good Clinical Practice (GCP)
Good Clinical Practice (GCP)
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Public and Patient Involvement (PPI)
Public and Patient Involvement (PPI)
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FINER criteria
FINER criteria
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Literature review
Literature review
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Aetiology & Mechanisms Research
Aetiology & Mechanisms Research
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Treatment Research
Treatment Research
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Experiences Research
Experiences Research
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Introduction section
Introduction section
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Aims, Objectives & Hypotheses
Aims, Objectives & Hypotheses
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Methods section
Methods section
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Good Research Question
Good Research Question
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PICO(T) Format
PICO(T) Format
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Population of Interest
Population of Interest
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Null Hypothesis
Null Hypothesis
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Alternate Hypothesis
Alternate Hypothesis
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Narrow Population Definition
Narrow Population Definition
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Broad Population Definition
Broad Population Definition
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External Validity
External Validity
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Internal Validity
Internal Validity
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Confounding Factors
Confounding Factors
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Study Notes
Research Questions and Design
- Developing good research questions, hypotheses, and objectives can be challenging.
- Critical appraisal of the research question is vital for applying findings to clinical practice.
- Dedicating resources, time, effort to developing elements (question, hypothesis, objective) is essential.
- Well-developed elements guide the project, influencing result interpretation, & impact publication efforts.
- Researchers should use available tips and guidelines to formulate key research components effectively.
FINER Criteria
- Feasible, Interesting, Novel, Ethical, Relevant
Origins of Research Questions
- Personal interest/experience/clinical observation/inspiration
- Immersion in literature is crucial for refining questions.
- Systematic literature review
- Incremental progress - fundamental for evolving research questions.
- Builds upon existing knowledge, refining methods, and expanding boundaries of understanding.
- Replications - helpful; especially with better methods/different groups.
- Theories - explain connections between factors; suggest ways to improve interventions.
- Stakeholder viewpoints are important (e.g., service users, carers).
Hypothesis
- A testable explanation for a phenomenon.
- Core of scientific method
- Any empirical study should have a hypothesis that clarifies the association between phenomena.
- In a study, more than one hypothesis is allowed, but one should be the main focus.
- Qualitative and descriptive studies may lack hypotheses but still have a specific research question.
- Example hypothesis - (e.g., people who report experiences of childhood physical abuse score higher on a measure of suspiciousness).
Types of MH Research Questions
- Aetiology & Mechanisms (understanding how and why mental health problems arise)
- Treatment (developing methods to prevent or alleviate mental health problems).
- Experiences (examining the lived experience of mental health problems).
Designing a Protocol
- Principles: start with a clearly defined question, write a protocol, methods have pros and cons
- Good designs are collaborative.
- Design should fit current knowledge and evidence.
- Keep it simple; publish protocol
Protocol Structure:
- Introduction: context, current evidence, and rationale.
- Aims & Objectives: key research question, hypothesis (if applicable).
- Methods: methods with relevant specifics (e.g., sample, procedures, data collection methods, data management and analysis, ethical considerations).
- Analysis plan
- Dissemination plan: strategy for distributing findings.
- Timing, staffing, ethics, research governance, costs
Other Protocol Elements
- Participants and Sampling/Recruitment
- Interventions and Controls
- Data Management and Analysis
- Ethical Considerations & Informed Consent
- Strengths and limitations
- Timeline
- Budget (or funding sources)
- Potential pitfalls and solutions
- Dissemination plan
- Dissemination goals, objectives (e.g., goals for dissemination, timeline, responsibilities, policy and practice implications, evaluation, resources, ethical considerations)
- Public and Patient Involvement (PPI)
Strengths and Weaknesses of a Research Protocol
- Strengths: reviews existing research, explains gaps in research, includes PPI aspects, contains an aim, contains methods section, describes the inclusion criteria or details.
- Weaknesses: vague language and criteria/variables, vague or inappropriate age groups, lacks reliability in how the study will be conducted, lack of explanation of key terms, too vague, no clear hypothesis, no quantifiable aim/hypothesis, no objective, no method of analysis, no review of confounding variables, no clear timelines.
Additional Elements
- State level of significance, specify statistical test and justify methods, describe handling of variables, review possible confounding variables
- Clearly defined approach to data collection (e.g., thematic analysis, grounded theory).
- Mention of appropriate software for analyses.
- Outline dissemination plan (target audience, channels).
Dissemination
- Target Audience/method or channels
- Other researchers, clinicians, patients, service planners, policy makers, general public
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